MAUDE Adverse Event Report: COVIDIEN VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number	VS-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Vasculitis (2004); Thrombus (2101)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient had bilateral great saphenous veins (gsv) treated with venaseal closure system, the right leg was treated in (b)(6) 2016 and the left leg was treated one month later, in (b)(6) 2016.The patient reported ((b)(6) 2017) of having side effects post procedure, which presented as vein leakage in her legs, a blood clot and scarring for which she is now seeking additional medical treatment.In follow-up on (b)(6) 2017, the patient reported that she had experienced scarring at the entry point on right leg, vein leakage and blood pooling, which had caused redness and weeping across the ankle area.Patient also reported that she had experienced thrombophlebitis in the left leg after the venaseal treatment, which was confirmed by an ultrasound during a follow-up appointment, blood pooling in left leg causing redness and weeping across the ankle area.Patient was seen by a wound specialist and a vascular physician for consultation on (b)(6) 2017.After performing bilateral ultrasounds, patient was provided with juxtafit compression wraps.
Additional Manufacturer Narrative
Update received ((b)(6) 2017): the patient attended a follow-up appointment with a vascular surgeon, at the (b)(6) on (b)(6) 2017.The physician reported ultrasound imaging did not show any evidence of acute or chronic dvt.The tested deep veins were seen to have competent valves.Segments of the right great saphenous vein were occluded in the thigh and leg, but venous incompetence at the saphenofemoral junction with valsalva maneuver could be seen.A patent segment of gsv in the lower thigh was incompetent, and a mild valvular incompetence was part of the gsv near the ankle.The right small saphenous vein was thrombosed in the upper leg to the saphenopopliteal junction, though there was a varicosity that rose at that level.On the left lower extremity, the gsv was thrombosed from the previous glue treatment.The patient had an incompetent anterior accessory vein in the upper thigh that gave rise to varicosities.The gsv in the leg was incompetent.Analysis summary: sample evaluation: two photographic images of the patient¿s legs were provided.The first photograph is of the patient¿s left leg and exhibits redness across the ankle area and possible blood pooling.The second photograph is of the patient¿s right leg and exhibits redness just above the ankle area.The two images confirm the reported symptoms from (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN; 951 aviation pkwy ste 900; morrisville NC 27560
• MDR Report Key: 6963761
• Report Number: 3011410703-2017-00428
• Device Sequence Number: 18974418
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: 10884521539921
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention